Therapeutic Options for Treatment of Burning Mouth Syndrome

Not Applicable

Completed

• Conditions: Burning Mouth Syndrome
• Interventions: Procedure: low level laser treatment with Ga-Al-As laser; Dietary Supplement: BioGaia Prodentis lozenges; Dietary Supplement: B vitamin injections (Neurobion, Merck, Darmstadt, Germany)

• Registration Number: NCT04475614
• Lead Sponsor: University of Zagreb

Brief Summary

Burning mouth syndrome is a painful condition of unknown etiology that impairs the quality of life and does not have an adequate therapeutic option. The purpose of this study is to determine the most effective treatment option for burning mouth syndrome, among oral probiotics, low-level laser, B-vitamin injections and informative treatment only.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-15
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-16
• Last Update Submitted: 2020-07-16
• Study First Posted: 2020-07-17
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• newly diagnosed with burning mouth syndrome and excluded local and systemic causes

Exclusion Criteria

• patients who have received treatment for burning mouth earlier
• patients with local or systemic causes of burning mouth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low level laser treatment	low level laser treatment with Ga-Al-As laser	The patients in this group, beside verbal and written information about their condition, received a total of ten low level laser treatments, for ten days consecutively excluding weekends.
oral probiotics	BioGaia Prodentis lozenges	The patients in this group, beside verbal and written information about their condition, received also oral probiotics. They were instructed to melt one lozenge in the mouth in the evening, after tooth brushing and flossing, for one month.
B-vitamin injections	B vitamin injections (Neurobion, Merck, Darmstadt, Germany)	The patients in this group, beside verbal and written information about their condition, received a total of nine B vitamin injections, every other day, intra muscular.

Primary Outcome Measures

Name	Time	Method
Change in the patient's quality of life using Oral Health Impact Profile 14 questionnaire (OHIP-14)	up to two months (follow up was one month after the end of treatment, in each patient)	change in the patient's quality of life determined by self-perceived quality of life questionnaire (Oral Health Impact Profile; OHIP-14)

Secondary Outcome Measures

Name	Time	Method
Change in subjective burning symptoms	up to two months (follow up was one month after the end of treatment, in each patient)	change of patient's subjective burning symptoms measured on visual analogue scale (VAS) grading from 0 to 10 (0- without burning, 10- the worst possible burning)

Trial Locations

Locations (1)

School of Dental Medicine, University of Zagreb; 🇭🇷 Zagreb, Croatia